An interventional study of Infant Sleep Hygiene Education Program in Sleep Hygiene, Infant Sleeping Habits and Parent Education, sponsored by Karabuk University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Karabuk University · Not applicable, Interventional, and Prevention
This randomized controlled trial aims to evaluate the effectiveness of a structured, Infant Sleep Hygiene Education Program initiated during pregnancy on infant sleep habits and parental self-efficacy related to infant sleep in the postpartum period. The program is grounded in developmental science and attachment-sensitive principles and focuses on promoting healthy sleep habits through responsive caregiving, consistent bedtime routines, and evidence-based sleep hygiene practices.
Pregnant women will be randomly assigned to either an intervention group receiving a multi-session prenatal education program with postnatal follow-up support, or a control group receiving routine antenatal care. Primary outcomes include parental self-efficacy regarding infant sleep and infant sleep habits (e.g., night awakenings, sleep duration, sleep onset latency, and routine consistency), assessed at 1, 3, and 6 months postpartum.
Secondary outcomes include adherence to recommended sleep-supportive parenting practices and infant sleep diary indicators. In addition, the mediating role of parental self-efficacy in the relationship between the intervention and infant sleep outcomes will be examined. Program evaluation outcomes will assess parental knowledge before and after the education, participation and adherence to the sessions, and parental satisfaction with the education program.
This study aims to provide evidence for an ethical, developmentally appropriate, and preventive infant sleep education model integrated into routine prenatal care.
Sleep is a critical determinant of infants' neurodevelopment, emotional regulation, and physical health, and early sleep problems are associated with adverse outcomes for both children and families. Parental perceptions of infant sleep and parental self-efficacy play a central role in shaping sleep-related caregiving practices. Although various infant sleep interventions exist, many are heterogeneous in content and intensity, and some behaviorally oriented approaches raise ethical and developmental concerns due to potential negative effects on parent-infant attachment and stress regulation. Moreover, structured, attachment-sensitive, and sleep hygiene-based educational interventions initiated during pregnancy remain limited in the literature.
This randomized controlled trial will evaluate the effectiveness of a structured Infant Sleep Hygiene Education Program delivered prenatally to pregnant women, with continued postnatal follow-up, on infant sleep habits and parental self-efficacy related to infant sleep. The intervention is grounded in developmental and attachment-informed principles and emphasizes ethical, responsive caregiving strategies rather than extinction-based sleep training methods. Core components of the program include:
developmentally appropriate sleep expectations, infant temperament-sensitive approaches, establishment of consistent and predictable bedtime routines, environmental sleep hygiene (light, noise, temperature), responsive soothing strategies, and parental coping and stress regulation skills. Participants will be randomly allocated to an intervention group or a control group receiving routine antenatal care. The education program will be delivered in multiple structured sessions during pregnancy and reinforced with postnatal follow-up support. Outcomes will be assessed at baseline (prenatal) and at 1, 3, and 6 months postpartum.
Primary outcomes are parental self-efficacy regarding infant sleep and infant sleep habits (e.g., night waking frequency, sleep duration, sleep onset latency, and routine consistency). Secondary outcomes include adherence to recommended sleep-supportive parenting practices and infant sleep diary indicators. In addition, the mediating role of parental self-efficacy in the relationship between the intervention and infant sleep outcomes will be examined.
Process and program evaluation outcomes will assess parental knowledge about infant sleep hygiene before and after the education program, adherence to the intervention content, completion of sleep diaries, and parental satisfaction with the education sessions.
This study aims to contribute to the development of an ethical, developmentally appropriate, and preventive infant sleep education model that supports healthy sleep habits while strengthening parental competence and promoting sustainable sleep-supportive caregiving practices. Findings may inform maternal-child health services and early preventive interventions integrated into routine prenatal care.
In addition to primary and secondary clinical outcomes, a process evaluation framework will be used to assess the implementation quality and feasibility of the education program. This will include assessment of parental knowledge about infant sleep before and after the education sessions, adherence to recommended sleep-supportive parenting practices, completion of infant sleep diaries, and participant satisfaction with each education session. Furthermore, the mediating role of parental self-efficacy in the relationship between the intervention and infant sleep outcomes will be examined to better understand the mechanisms of change.
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
This study's planned enrollment of 48 is below the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Browse Sleep Hygiene studies →Karabuk University is the lead sponsor of 143 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Participants in this arm will receive a structured, parent-centred Infant Sleep Hygiene Education Program delivered in multiple sessions during pregnancy, followed by standardized postnatal follow-up support. The program is grounded in developmental and attachment-informed principles and focuses on responsive caregiving, establishment of consistent bedtime routines, and evidence-based sleep hygiene practices.
Behavioral: Infant Sleep Hygiene Education Program
Participants in this arm will receive routine antenatal care according to standard clinical practice, without any additional structured education related to infant sleep or postnatal follow-up support.
Participants will receive a structured, parent-centred Infant Sleep Hygiene Education Program delivered in multiple sessions during pregnancy, with postnatal follow-up support. The program is based on developmental and attachment-informed principles and focuses on responsive caregiving, establishing consistent bedtime routines, and evidence-based sleep hygiene practices, including environmental adjustments, soothing strategies, and parental coping skills.
Also known as: Prenatal Parent Sleep Education Program
Parental self-efficacy regarding infant sleep
Parental confidence in managing and supporting their infant's sleep will be assessed using the validated Turkish version of the Uppsala Parental Self-Efficacy about Infant Sleep Instrument (UPPSEISI). The UPPSEISI is an 11-item, two-factor, 5-point Likert-type scale that assesses parental self-efficacy related to infant sleep. It consists of two subscales: Child Sleep Needs (6 items), which measures parents' self-efficacy in managing difficulties related to ensuring that the child sleeps sufficiently at appropriate times, and Difficult Parenting (5 items), which assesses parents' self-efficacy in coping with practical challenges of putting the child to sleep and difficulties arising from the parent's own disrupted sleep. Total scores range from 11 to 55, with higher scores indicating greater parental self-efficacy in managing infant sleep-related challenges.
Time frame: Baseline (prenatal), 1 month, 3 months, and 6 months postpartum
Brief Infant Sleep Questionnaire-Revised (BISQ-R)
The scale is a parent-reported questionnaire used to assess infants' and toddlers' sleep patterns and sleep-related behaviors. The Brief Infant Sleep Questionnaire-Revised (BISQ-R) assesses sleep over the previous two weeks in children aged 0-36 months and includes items on demographic characteristics and infant sleep. The questionnaire evaluates three main domains: Infant Sleep, Parent Perception, and Parent Behavior. Scores are scaled from 0 to 100, with higher scores indicating better sleep quality, more positive parental perceptions of infant sleep, and parental behaviors that support healthy and
Time frame: 1 months, 3 months, and 6 months postpartum
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data collected in this study will be analyzed and reported in aggregate form in the thesis and related publications. Individual participant-level data will not be shared with external researchers. All analyses will use anonymized data to protect participant privacy.
Start is estimated for Jun 2026; primary completion for Aug 2026, 2 months later.
Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's planned 2 months is below that.
Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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